AUTHORIZATION HOLDER SERVICE – FOR BIOCIDAL PRODUCTS
All biocidal products require authorisation before they can be placed on the market. The active substances contained in the biocidal products must be previously approved. However, the substance which is in the Review Programme can be made available on the market (subject to national laws) until the final decision on the approval of the active substance (and up to 3 years after).
Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorization is granted.
‘Authorisation Holder’ means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorization.
All biocidal products must get authorisation before they can be made available on the market. Companies can choose between several alternative processes, depending on their product and the number of countries where they wish to sell it.
National authorization and mutual recognition
If the product will be placed only on a single market, authorization from that country is sufficient.
If a company wishes to place the product on the market in several countries, it can apply for mutual recognition for product authorization.
The authorization holder can apply for the renewal of authorization to the Member State competent authority (MSCA) who granted the authorization. In case of mutual recognition authorization, the application for renewal should be submitted to the reference MSCA and all MSCAs concerned.
The Biocidal Products Regulation introduces a new alternative for companies that wish to apply for an EU-wide authorization in one go.
There is also a simplified procedure for products which meet certain criteria specified in the regulation, e.g. do not contain any substances of concern.
Same biocidal product authorization
There is the possibility to apply for an authorization of a biocidal product, which is either identical to an already authorized biocidal product or identical to a biocidal product for which an application for authorization is ongoing.
Let BIA Ltd be your Authorisation Holder and get the authorization for your biocidal product!
We offer EU- Responsible Person – Authorization Holder service and registered address in Europe.
- Classification of the biocidal product to the appropriate group
- Choosing the authorization type (depending on the product, active substance and the number of countries where the product will be sold)
- Preparing documentation to place on the European market
- Ordering required laboratory tests
- Filling out and submitting the application for authorization
- Creation of EU-compliant label draft of biocidal product
Read more about Biocidal Products
The approval of active substances takes place at Union level and the subsequent authorization of the biocidal products at Member State level. This authorization can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorization at Union level (Union authorization).
A dedicated IT platform, the Register for Biocidal Products (R4BP 3), will be used for submitting applications, exchanging data and information between the applicant, ECHA, Member State competent authorities, and the European Commission. Another IT tool, IUCLID, is used for preparing the applications.
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances, contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.
Active substances and suppliers
From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs (included in the Article 95 list).
In Annex V to the BPR the biocidal products are classified into 22 biocidal product-types, grouped in four main areas.